Weekly Roundup 4.29.16

Goodbye April. It was nice knowing you.

There were a lot of noteworthy developments this week and I would like to write about them all, but as usual, will pick only a few from the bunch.

  • FDA Issues Complete Response Letter for First Digital Medicine – In September 2015, two companies announced they were submitting an NDA for the first “digital medicine” – a combination product of an FDA approved medication with an embedded sensor. In this case, the medication was ABILITY, approved for the treatment of several mental health conditions and it was being combined with a sensor that would, among other things, measure adherence.  This week FDA issued a complete response letter regarding the application, according to the companies, indicating that the agency would like to see further data regarding the performance of the product under conditions in which it would be used.
  • Lawsuit Brought Regarding Advisory Committee Redacted CVs Public Citizen announced this week that the organization had brought a lawsuit regarding redacted Curricula Vitae of FDA Advisory Committee members. As any regular reviewer of these CVs will know, information regarding specific details of an individual advisory committee member’s information is often redacted – some of it personal information, some of it associated with grants. Public Citizen makes the point that confidential information is not generally included on documents that are in fact meant to be shared.
  • First Commercial Zika Test Approved – There will be an increasing amount of news about Zika in the coming months. Ironically while this week there was the first U.S. death reported in the media attributed to infection with Zika occurring in Puerto Rico, there was also an announcement that the FDA had authorized the first commercial test for Zika for emergency use. Until now, testing was only available through the CDC and using specified labs but the new test will be made broadly available next week throughout the U.S.

That’s it for me this week. Have a good weekend everyone.

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